# K083398: Cercom Cement

- Pathway: 510(k) (Traditional)
- Applicant: Denali R&D Corporation
- Decided: Jan 26, 2009 after 70 days
- Product code: EMA (Cement, Dental)
- Device class: 2
- Regulation: 21 CFR 872.3275
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) RelyX Cement, ESPE/3M: named in the summary without a submission number
- (no number) Varolink Cement, Ivoclar: named in the summary without a submission number
- (no number) Calibra Cement, Dentsply: named in the summary without a submission number
- (no number) Nexus Cement, Kerr: named in the summary without a submission number

## Indications for use
CERCOM Cement is a self-adhesive cement recomnmended for the bonding of ceramic and composite restorations

Source page: https://510kreport.com/device/K083398
Methodology: https://510kreport.com/methodology